Albumin-based pharmaceutical compositions have been developed as a drug delivery system for delivering substantially water insoluble drugs such as a taxane. See, for example, U.S. Pat. Nos. 5,916,596, 6,506,405, 6,749,868, 6,537,579, 7,820,788, and 7,923,536. ABRAXANE®, an albumin-stabilized nanoparticle formulation of paclitaxel (“nab-paclitaxel”), is a prescription drug approved to treat life-threatening cancers that affect hundreds of thousands of patients in the United States. It is indicated for the treatment of metastatic breast cancer, locally advanced or metastatic non-small cell lung cancer (“NSCLC”), as well as metastatic adenocarcinoma of the pancreas.
It is generally believed that albumin-based nanoparticles, such as those in nab-paclitaxel sold under the trademark ABRAXANE®, when introduced into the blood stream, would dissolve into albumin-drug complexes. Such albumin-drug complexes utilize the natural properties of albumin to transport and deliver substantially water insoluble drugs to the site of disease, such as tumor sites. In addition, the albumin-based nanoparticle technology offers the ability to improve a drug's solubility without the need for toxic solvents in the administration process, thus potentially improving safety through the elimination of solvent-related side effects.
The disclosures of all publications, patents, patent applications, and published patent applications referred to herein are hereby incorporated herein by reference in their entireties.